A Better Treatment for Patients with BRAF V600E–Mutant Colon Cancer

Patients had superior overall survival when clinicians added encorafenib and cetuximab to first-line chemotherapy.

In 2024, the FDA granted fast-track approval for the addition of encorafenib and cetuximab to first-line mFOLFOX6 chemotherapy for patients with BRAF V600E–mutant colon cancer based on the combination's superior response rate over chemotherapy alone in the BREAKWATER trial (NEJM JW Oncol Hematol Mar 26 2025 and Nat Med 2025; 31:901). Investigators now report an update on other endpoints from this industry-sponsored, open-label, randomized, phase 3 trial.

Patients received one of three treatment combinations:

Encorafenib, cetuximab, and mFOLFOX6 (EC-mFOLFOX6)
Standard-of-care chemotherapy: 5-FU, capecitabine, oxaliplatin, or irinotecan combination therapy with or without bevacizumab (SOC)
Encorafenib and cetuximab without chemotherapy (EC); this…

Reviewing Author

David H. Ilson, MD, PhD

Disclosures

Consultant/Advisory BoardAstraZeneca; Merck; Taiho; Astellas; Bristol Myers Squibb; Regeneron; Oncolys; Amgen; Daiichi Sankyo

David H. Ilson, MD, PhD

Disclosures

Consultant/Advisory BoardAstraZeneca; Merck; Taiho; Astellas; Bristol Myers Squibb; Regeneron; Oncolys; Amgen; Daiichi Sankyo

A Better Treatment for Patients with BRAF V600E–Mutant Colon Cancer

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Reviewing Author